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CN113769284A - Ultrasonic aortic valve forming device - Google Patents

Ultrasonic aortic valve forming device Download PDF

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Publication number
CN113769284A
CN113769284A CN202111256471.5A CN202111256471A CN113769284A CN 113769284 A CN113769284 A CN 113769284A CN 202111256471 A CN202111256471 A CN 202111256471A CN 113769284 A CN113769284 A CN 113769284A
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Prior art keywords
ultrasonic
balloon
piezoelectric transducer
aortic valve
catheter
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CN202111256471.5A
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Inventor
陈澍
杨琼
王诗龄
廖曼
董念国
夏家红
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Priority to CN202111256471.5A priority Critical patent/CN113769284A/en
Publication of CN113769284A publication Critical patent/CN113769284A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system
    • A61M2210/125Heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system
    • A61M2210/127Aorta
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N2007/0039Ultrasound therapy using microbubbles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N2007/0043Ultrasound therapy intra-cavitary

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Surgical Instruments (AREA)

Abstract

本发明公开了一种超声主动脉瓣成形装置,属于医疗器械技术领域。超声主动脉瓣成形装置包括球囊、控制手柄、导管和超声发生器。球囊包含用于容纳液态介质的容置腔;控制手柄上具有冲水口;导管的第一端与冲水口联通,导管的第二端贯穿球囊,第二端具有出水口,出水口与的容置腔联通,第二端具有压电换能器,压电换能器位于球囊的容置腔内。球囊内的液态介质在超声作用下产生空化气泡,气泡破裂产生能量作用于钙化区域,使钙化沉积物产生裂缝和结构变化,从而去除主动脉瓣上的钙化沉积物,恢复钙化狭窄的自体主动脉瓣的功能,进而起到瓣膜成形的效果。本装置可以实现无植入情况下恢复自体钙化瓣膜的柔软和功能,避免介入主动脉瓣植入装置的缺点。

Figure 202111256471

The invention discloses an ultrasonic aortic valve shaping device, which belongs to the technical field of medical devices. The ultrasonic aortic valve forming device includes a balloon, a control handle, a catheter and an ultrasonic generator. The balloon contains an accommodating cavity for accommodating the liquid medium; the control handle is provided with a flushing port; the first end of the catheter is communicated with the flushing port, the second end of the catheter penetrates the balloon, and the second end has a water outlet, which is connected with the water outlet. The accommodating cavity is communicated, the second end is provided with a piezoelectric transducer, and the piezoelectric transducer is located in the accommodating cavity of the balloon. The liquid medium in the balloon generates cavitation bubbles under the action of ultrasound, and the bursting of the bubbles generates energy to act on the calcified area, causing cracks and structural changes in the calcified deposits, thereby removing the calcified deposits on the aortic valve and restoring the calcified stenosis. The function of the aortic valve, which in turn has the effect of valvuloplasty. The device can restore the softness and function of the autologous calcified valve without implantation, and avoid the shortcomings of intervening the aortic valve implantation device.

Figure 202111256471

Description

Ultrasonic aortic valve forming device
Technical Field
The invention relates to the technical field of medical instruments, in particular to an ultrasonic aortic valve forming device.
Background
Valvular heart disease is an important killer affecting the life health of people, especially senile valvular heart disease, and degenerative aortic stenosis is the most common senile valvular heart disease. The incidence of aortic stenosis increases with age, 0.2% between 50 and 59 years old, 1.3% between 60 and 69 years old, 3.9% between 70 and 79 years old, and 9.8% between 80 and 89 years old. The major pathological change in senile degenerative aortic valve disease is calcification of the valve, which is a gradual accumulation of calcium and phosphate minerals, whose deposition thickens the valve leaflets, forming mineralized structures. Dystrophic calcification concentrates in areas of greatest mechanical stress, leading to progressive deterioration of cardiac hemodynamics.
At present, for patients with severe aortic stenosis, valve replacement methods are basically adopted for treatment, and include open heart surgery, transcatheter valve replacement surgery and the like. Transcatheter aortic valve replacement has brought old aortic valve disease into a new stage in recent years. The method is minimally invasive, does not need extracorporeal circulation, and can complete replacement of the valve without opening the chest.
However, this method also has some inherent drawbacks: the need to implant new valve devices presents a problem of longevity; the new valve is limited by the size of the valve ring, and if the valve needs to intervene again, the problem of insufficient size can exist; the stent of the implanted new valve may block the opening of the coronary artery itself, and may not be able to perform when the coronary artery again needs interventional intervention in the future, etc.
Disclosure of Invention
In order to avoid the disadvantages of the interventional aortic valve implantation device, the embodiment of the present invention provides an ultrasonic aortic valve shaping device. The technical scheme is as follows:
the embodiment of the invention provides an ultrasonic aortic valve forming device. The method specifically comprises the following steps:
the balloon comprises a containing cavity for containing a liquid medium;
the control handle is provided with a flushing port;
a catheter, a first end of the catheter is communicated with the flushing port, a second end of the catheter penetrates through the balloon, the second end is provided with a water outlet, the water outlet is communicated with the accommodating cavity, the second end is provided with a piezoelectric transducer, and the piezoelectric transducer is located in the accommodating cavity of the balloon; and
the ultrasonic generator is electrically connected with the piezoelectric transducer and provides ultrasonic waves for the piezoelectric transducer.
Further, the ultrasonic wave is a cyclic sound wave formed by a positive pressure pulse and a negative pressure pulse, and the pulse period is 20-50 ns.
Furthermore, the frequency of the piezoelectric transducer is 80-120 Hz.
Further, the second end is provided with two piezoelectric transducers, the frequency of one piezoelectric transducer is 80-120 Hz, and the frequency of the other piezoelectric transducer is 2-5 Hz.
Further, the piezoelectric transducer is embedded in the second end of the conduit.
Further, the ultrasonic generator is electrically connected with the piezoelectric transducer through the control handle and the catheter, a switch is arranged on the control handle, and the switch is used for controlling the on and off of the ultrasonic generator.
Further, the diameter of the middle part of the balloon is smaller than the diameters of the two ends of the balloon.
Further, the diameter of the middle portion of the balloon is at least 15% smaller than the diameter of the ends of the balloon.
Further, the diameter of the middle of the balloon is 18-28 mm.
Further, the end of the balloon has a positioning metal that is opaque to X-rays.
The technical scheme provided by the embodiment of the invention has the beneficial effects that at least:
the ultrasonic aortic valvuloplasty device comprises a balloon, a control handle, a catheter and an ultrasonic generator. The balloon comprises a containing cavity for containing a liquid medium; the control handle is provided with a flushing port; the first end of the conduit is communicated with the flushing port, the second end of the conduit penetrates through the balloon, the second end is provided with a water outlet, the water outlet is communicated with the accommodating cavity, the second end is provided with a piezoelectric transducer, and the piezoelectric transducer is positioned in the accommodating cavity of the balloon; and the ultrasonic generator is electrically connected with the piezoelectric transducer. Liquid medium is injected into the saccule through a flushing port of the catheter, the piezoelectric transducer releases ultrasonic waves emitted by the ultrasonic generator into the accommodating cavity of the saccule filled with the liquid medium, and when bubbles in the liquid medium are exposed to an ultrasonic field, the sound field can generate 2 different acoustic cavitation effects of inertia (transient state) and non-inertia (stable). When the frequency of the sound field approaches the proper frequency of the bubble, a resonance phenomenon occurs. During the collapse process, the bubbles may break into small bubbles, collapse directly, or repeat the expansion and collapse cycle. The implosion of the bubbles causes mechanical erosion (mechanical erosion) due to the concentrated release of energy. The liquid medium in the saccule generates cavitation bubbles under the action of ultrasound, the bubbles are broken to generate energy to act on a calcified area, and the calcified deposits generate cracks and structural changes, so that the calcified deposits on the aortic valve are removed, the function of calcified narrow autologous aortic valve is recovered, and the valve forming effect is achieved.
The device can restore the softness and the function of the self-calcified valve under the condition of no implantation, avoids the defect of an interventional aortic valve implantation device, and has very obvious advantages for patients who are in the preclinical stage and have not progressed to severe aortic stenosis but have valve calcification to influence the activity of valve leaflets.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.
FIG. 1 is a schematic structural diagram of an ultrasonic aortic valvuloplasty apparatus provided by an embodiment of the present invention;
fig. 2 is a schematic view of the use of an ultrasonic aortic valvuloplasty device of the present invention.
Reference numerals:
a balloon 10, a control handle 20, a catheter 30, an ultrasonic generator 40,
The flushing port 21, the first end 31, the second end 32, the piezoelectric transducer 11 and the guide wire 12;
left ventricle 100, aortic orifice 200
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
Fig. 1 is a schematic structural diagram of an ultrasonic aortic valvuloplasty apparatus provided by an embodiment of the present invention. As shown in fig. 1, the ultrasonic aortic valvuloplasty apparatus includes a balloon 10, a control handle 20, a catheter 30 and an ultrasonic generator 40. The balloon 10 comprises a containing cavity for containing a liquid medium; the control handle 20 is provided with a flushing port 21; the first end 31 of the conduit 30 is communicated with the flushing port 21, the second end 32 of the conduit 30 penetrates through the balloon 10, the second end 32 is provided with a water outlet which is communicated with the accommodating cavity, the second end 32 is provided with a piezoelectric transducer 11, and the piezoelectric transducer 11 is positioned in the accommodating cavity of the balloon 10; the ultrasonic generator 40 is electrically connected to the piezoelectric transducer 11.
Liquid medium is injected into the balloon 10 through the flushing port 21 of the catheter 30, the piezoelectric transducer 11 releases ultrasonic waves emitted by the ultrasonic generator 40 into the accommodating cavity of the balloon 10, and when bubbles in the liquid medium are exposed to an ultrasonic field, the sound field can generate 2 different acoustic cavitation effects of inertia (transient state) and non-inertia (stable state). Acoustic pressure, as an external force, can change its radius, the bubble behaves like an oscillating system, its elasticity is determined by the gas inside, its inertia is determined by the liquid surrounding the bubble, it oscillates together with the wall of the bubble itself. When the frequency of the sound field approaches the proper frequency of the bubble, a resonance phenomenon occurs. During the collapse process, the bubbles may break into small bubbles, collapse directly, or repeat the expansion and collapse cycle. The implosion of the bubbles causes mechanical erosion (mechanical erosion) due to the concentrated release of energy. The liquid medium in the saccule generates cavitation bubbles under the action of ultrasound, and the bubbles are broken to generate energy to act on the calcified area, so that calcified deposits on the aortic valve are removed, the function of calcified narrow autologous aortic valve is recovered, and the valvuloplasty effect is achieved. The device can avoid the defects of an interventional aortic valve implantation device, and has obvious advantages for patients who do not progress to severe aortic stenosis in the preclinical stage but have valve calcification which influences the activity of valve leaflets.
In some embodiments, the ultrasonic wave is a cyclic sound wave formed by one positive pressure pulse and one negative pressure pulse, and the pulse period is 20-50 ns. Cavitation bubbles are inherently unstable, they expand during the negative phase of the pressure wave and disintegrate rapidly and violently upon arrival of the positive phase, and repeated application of pulses creates a "bubble cloud" localized in the focus of the ultrasound field, increasing the cavitation effect.
Furthermore, the frequency of the piezoelectric transducer 11 is 80-120 Hz to avoid that higher frequency sound waves can increase heat generation and affect heart tissues.
Further, the second end 32 of the conduit 30 may also have two piezoelectric transducers 11, one piezoelectric transducer 11 having a frequency of 80-120 Hz and the other piezoelectric transducer 11 having a frequency of 2-5 Hz. Under the condition of the same power, the two frequencies are combined together, the number of generated bubbles is 5 times that of the bubbles generated by using a single frequency, and when the power is lower, the number of generated bubbles is more in the double frequency. By combining the ultrasonic fields of the two frequencies, the low frequency stimulation expands the cavitation volume by amplifying the cavitation effect generated by the high frequency, resulting in an increase in the cavitation effect.
In implementation, the piezoelectric transducer 11 is embedded in the second end 32 of the conduit 30. Specifically, the outer diameter of the piezoelectric transducer 11 is the same as the inner diameter of the conduit 30, so that the piezoelectric transducer 11 is embedded in the second end 32 of the conduit 30 and is not easy to fall off.
In some embodiments, the ultrasonic generator 40 is electrically connected to the piezoelectric transducer 11 through the control handle 20 and the catheter 30, and the control handle 20 is provided with a switch 22, and the switch 22 is used for controlling the on and off of the ultrasonic generator 40. Specifically, the conduit 30 is a hollow conduit having a metal layer covered with an insulating layer on the inside and outside, the metal layer being used to transmit an electrical signal to the piezoelectric transducer 11. The hollow catheter can be used as a flow channel for liquid medium to inject the liquid medium into the balloon 10. Preferably, the metal layer may be a metal layer woven from metal wires.
Further, the hollow region inside the catheter 30 can be threaded with a guide wire, and the position of the interventional device can be controlled through the guide wire 12, so that the whole ultrasonic aortic valvuloplasty device can be guided and positioned.
Fig. 2 is a schematic diagram of the use of the ultrasonic aortic valvuloplasty apparatus of the present invention, and as shown in fig. 2, the diameter of the middle of the balloon 10 is smaller than the diameters of the two ends of the balloon 10, so that the balloon 10 is peanut-shaped to be better fixed at the stenotic aortic valve orifice 200 to avoid displacement caused by blood flow impact.
Further, the diameter of the middle part of the balloon 10 is at least 15% smaller than the diameter of the two ends of the balloon 10, and preferably, the diameter of the middle part of the balloon 10 is 18-28 mm. The balloon 10 may be of various sizes to accommodate valves of different stenosis degrees. For example, the diameter of the middle of the balloon 10 is 18-28 mm, one model per 2 mm.
Further, the end of the balloon 10 has a positioning metal that is opaque to X-rays, and under X-rays, the position of the balloon 10 can be determined by the position of the metal.
Further, the liquid medium is a mixture of physiological saline and a contrast agent to indicate the state of the balloon 10 under X-rays.
The method of using the ultrasonic aortic valvuloplasty apparatus is described below in conjunction with FIG. 2. First, the puncture femoral vein is inserted into the vascular protective sheath, a temporary pacing lead is inserted into the right ventricular wall, the guide wire is used to guide the catheter to the aortic root, and the guide catheter is exchanged, the guide wire is used to cross the stenotic aortic orifice 200 and the guide catheter is inserted into the left ventricle 100. The superhard guidewire is exchanged within the left ventricle 100. The balloon 10 is placed over the super hard wire to the stenotic aortic orifice 200. The temporary pacemaker paces the ventricular rate to 180bpm and fills the balloon with saline containing the contrast agent for 10 to 2atm while ultrasonic decalcification is initiated.
Pacing is stopped after 1 minute and the balloon 10 is evacuated so that blood can flow back out the edges of the balloon 10. After the blood pressure is recovered, the operation can be repeated again until the pressure difference of the aortic valve orifice 200 monitored by the ultrasonic wave is reduced to be below 30mmHg and the valve leaflets recover to move. The balloons with different sizes can be replaced on the way to obtain the best effect. After completion, the device can be withdrawn, and hemostasis can be pressed or sutured with a vascular closure device.
The present invention is not limited to the above preferred embodiments, and any modifications, equivalent replacements, improvements, etc. within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (10)

1. An ultrasonic aortic valvuloplasty device, characterized in that the ultrasonic aortic valvuloplasty device comprises:
a balloon (10), the balloon (10) comprising a receiving chamber for receiving a liquid medium;
a control handle (20), wherein the control handle (20) is provided with a flushing port (21);
a catheter (30), a first end (31) of the catheter (30) is communicated with the flushing port (21), a second end (32) of the catheter (30) penetrates through the balloon (10), the second end (32) is provided with a water outlet which is communicated with the accommodating cavity, the second end (32) is provided with a piezoelectric transducer (11), and the piezoelectric transducer (11) is positioned in the accommodating cavity of the balloon (10); and
an ultrasonic generator (40), wherein the ultrasonic generator (40) is electrically connected with the piezoelectric transducer (11) and provides ultrasonic waves for the piezoelectric transducer (11).
2. The ultrasonic aortic valve shaping device as claimed in claim 1, wherein the ultrasonic wave is a cyclic sound wave formed by one positive pressure pulse and one negative pressure pulse, and the pulse period is 20-50 ns.
3. The ultrasonic aortic valvuloplasty device of claim 1 wherein the piezoelectric transducer (11) has a frequency of 80-120 Hz.
4. The ultrasonic aortic valve shaping device of claim 1 wherein the second end (32) has two piezoelectric transducers (11), one of the piezoelectric transducers (11) having a frequency of 80-120 Hz and the other of the piezoelectric transducers (11) having a frequency of 2-5 Hz.
5. The ultrasonic aortic valvuloplasty device of claim 4, wherein the piezoelectric transducer (11) is embedded into the second end (32) of the catheter (30).
6. The ultrasonic aortic valve shaping apparatus according to claim 1, wherein the ultrasonic generator (40) is electrically connected to the piezoelectric transducer (11) through the control handle (20) and the catheter (30), and a switch is provided on the control handle (20) for controlling the ultrasonic wave of the ultrasonic generator (40) to be turned on and off.
7. The ultrasonic aortic valve shaping device according to any one of claims 1 to 6, wherein the diameter of the middle of the balloon (10) is smaller than the diameter of the two ends of the balloon (10).
8. The ultrasonic aortic valvuloplasty device of claim 7, wherein the diameter of the middle of the balloon (10) is at least 15% smaller than the diameter of the ends of the balloon (10).
9. The ultrasonic aortic valvuloplasty device of claim 7 wherein the diameter of the middle portion of the balloon (10) is 18-28 mm.
10. The ultrasonic aortic valvuloplasty device of any one of claims 1 to 6 wherein the end of the balloon (10) has a positioning metal that is opaque to X-rays.
CN202111256471.5A 2021-10-27 2021-10-27 Ultrasonic aortic valve forming device Pending CN113769284A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025036046A1 (en) * 2023-08-17 2025-02-20 叶秩光 Ultrasound balloon catheter

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5295958A (en) * 1991-04-04 1994-03-22 Shturman Cardiology Systems, Inc. Method and apparatus for in vivo heart valve decalcification
CN110314834A (en) * 2018-03-28 2019-10-11 中国科学院深圳先进技术研究院 A kind of ultrasonic transducer and preparation method thereof
CN110604607A (en) * 2019-08-06 2019-12-24 沛嘉医疗科技(苏州)有限公司 Shock wave device for treating calcification of heart valve
CN113490459A (en) * 2019-01-24 2021-10-08 艾奥迪可实验室有限责任公司 Device for treating tissue calcification
CN216258775U (en) * 2021-10-27 2022-04-12 华中科技大学同济医学院附属协和医院 Ultrasonic aortic valve forming device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5295958A (en) * 1991-04-04 1994-03-22 Shturman Cardiology Systems, Inc. Method and apparatus for in vivo heart valve decalcification
CN110314834A (en) * 2018-03-28 2019-10-11 中国科学院深圳先进技术研究院 A kind of ultrasonic transducer and preparation method thereof
CN113490459A (en) * 2019-01-24 2021-10-08 艾奥迪可实验室有限责任公司 Device for treating tissue calcification
CN110604607A (en) * 2019-08-06 2019-12-24 沛嘉医疗科技(苏州)有限公司 Shock wave device for treating calcification of heart valve
CN216258775U (en) * 2021-10-27 2022-04-12 华中科技大学同济医学院附属协和医院 Ultrasonic aortic valve forming device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025036046A1 (en) * 2023-08-17 2025-02-20 叶秩光 Ultrasound balloon catheter

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